Lifestyle Intervention for Obesity

(LIVE WELL Trial)

Overseen By Madison Kindred, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Augusta University

Disqualifiers: Cardiopulmonary disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the most effective method for weight loss and maintenance through a combination of diet, exercise, and motivational support. Participants will either follow a personalized diet plan based on their genetics or a standard diet plan, with both groups engaging in regular exercise. The researchers seek to identify which approach results in better weight loss and maintenance. Ideal participants are adults who have been overweight or obese (BMI over 25) for some time and can engage in physical activities independently. As an unphased trial, this study provides participants the chance to contribute to innovative weight loss strategies that could benefit many others in the future.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it requires that you have been stable on your medications for the past 3 months.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using genes to create a personalized diet, known as nutrigenomics, can aid in weight loss. One study found that participants on a personalized high-protein diet lost twice as much fat as those on a regular low-protein diet. This suggests that selecting foods based on genetics can effectively manage weight.

Studies have confirmed the safety of this genetic-based diet advice, indicating it is safe for weight management. No major side effects have been reported, demonstrating that participants generally tolerate this approach well.

For those considering joining a study that uses genetics to guide diet, current research supports its safety and potential effectiveness for weight loss. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Lifestyle Intervention for Healthy Change" because it offers a personalized approach to tackling obesity, which is different from the usual one-size-fits-all methods. Unlike standard treatments that often provide generic dietary advice, this intervention uses genetic information from an oral swab to tailor dietary plans specifically to each participant's unique genetic makeup. This customization could lead to more effective and sustainable weight management outcomes. Additionally, integrating both personalized diet and increased physical activity makes this approach a comprehensive lifestyle change, potentially enhancing overall health and well-being.

What evidence suggests that this trial's lifestyle interventions could be effective for obesity?

Research has shown that nutrigenomics, which involves creating diets based on genes, can aid in weight loss. In this trial, participants in the Nutrigenomix arm will receive personalized dietary plans based on genetic testing. Studies have found that a high-protein diet customized through genetic testing can result in losing twice as much body fat compared to a regular low-protein diet. Additionally, people who follow gene-tailored diets often maintain healthier eating habits over time. This method may help reduce fat intake and improve adherence to a diet long-term, which is crucial for lasting weight loss. While results can vary, promising evidence suggests that personalized nutrition could be a powerful tool against obesity. ^{1 2 6 7 8}

Who Is on the Research Team?

Madison Kindred, PhD

Principal Investigator

Augusta University

Are You a Good Fit for This Trial?

This trial is for overweight or obese adults aged 18-40 with a BMI over 25, who are stable on medications, not pregnant, can walk unassisted, and own a smartphone. It excludes those with cardiopulmonary disease or recent weight fluctuations.

Inclusion Criteria

stable on medications for 3 months

weight stable (+/-5 pounds) for the past 3 months

I do not have heart or lung disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a personalized or standard care diet plan and participate in an exercise intervention for 6 months

6 months

Regular visits for dietary and exercise monitoring

No Contact Phase

Participants complete a 3-month no contact phase to assess weight loss maintenance

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lifestyle Intervention for Healthy Change

Trial Overview The study tests a physician-led approach to obesity treatment combining personalized dietary plans based on genetics (Nutrigenomix), exercise routines, and motivational counseling. Participants will follow their diet and exercise plan for six months.

How Is the Trial Designed?

Group I: Nutrigenomix Experimental Treatment 3 Interventions

Participants in this group will be asked to complete an oral swab at baseline. This swab will indicate their dietary needs based on their genetic composition. These personalized dietary needs will be shared with the participant; the participant will be encouraged to follow their dietary plan for the duration of the study. Participants in this group will also gradually increase their physical activity up to 300 min/week at 6 months.

Group II: Control Active Control 3 Interventions

Participants in this group will receive a standard care dietary plan. They will also be asked to gradually increase their activity up to 300 min/week by 6 months.

Who Is Running the Clinical Trial?

Augusta University

Lead Sponsor

Trials

219

Recruited

85,900+

Published Research Related to This Trial

Lifestyle modifications for treating obesity are challenging to implement and sustain long-term, highlighting the need for effective strategies.

Simple and cost-effective interventions have shown potential benefits in specific populations, suggesting that targeted approaches may improve obesity treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Lifestyle modification--a behavioral and educational challenge]. Tamir, O., Furmn-Assaf, S., Shemer, J.[2011]

Lifestyle interventions that combine dietary changes, physical activity support, and weight management education are the first-line treatment for obesity, emphasizing their importance in addressing the global obesity epidemic.

The chapter highlights the need for personalized weight management programs to enhance effectiveness and long-term adherence, given the significant health risks associated with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss Strategies. Roberts, SB., Anton, S., Dao, MC.[2022]

Comprehensive lifestyle modification programs delivered in person can lead to an average weight loss of about 10% over 16-26 weeks, while web-based interventions typically result in around 5% weight loss, highlighting the effectiveness of in-person support.

Combining lifestyle changes with long-term medication use may enhance initial weight loss and help maintain weight loss over time, suggesting a multi-faceted approach could be beneficial for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior therapy for obesity: where are we now? Sarwer, DB., von Sydow Green, A., Vetter, ML., et al.[2022]

Lifestyle modification therapy can lead to a significant weight loss of 8-10% over approximately 30 weeks for overweight and obese patients, combining diet, exercise, and behavioral strategies.

To enhance the effectiveness and sustainability of this therapy, new strategies such as individualized treatment, remote delivery via phone or internet, and integration with community programs or bariatric surgery have shown promising results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle modification in the management of obesity: achievements and challenges. Dalle Grave, R., Calugi, S., El Ghoch, M.[2022]

A lifestyle intervention program combining diet, exercise, and psychological support significantly improved lifestyle-related behaviors in 60 overweight and obese patients over 6 months, as evidenced by better scores in dietary caloric intake, physical activity, and healthy eating.

The program also led to positive changes in body composition parameters, indicating that such comprehensive interventions can effectively support weight management in a primary healthcare setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of a program for treatment of overweight and nonmorbid obesity in primary healthcare and its influence lifestyle modification]. Arrebola Vivas, E., Gómez-Candela, C., Fernández Fernández, C., et al.[2015]

Lifestyle interventions can lead to weight loss and health benefits, as shown in large randomized clinical trials, but not all participants achieve even a 5% reduction in body weight, and weight regain is a common issue.

Real-world studies show only modest weight loss from lifestyle changes, and there is currently no reimbursement model to support these interventions in medical office settings, highlighting the need for healthcare providers to understand both the potential and limitations of these approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle-Based Obesity Care. Ryan, DH.[2023]

Individuals with severe obesity experience a complex and dynamic process of maintaining lifestyle changes three years after intervention, characterized by ups and downs in their daily lives.

Support from healthcare providers and a collaborative, humanized approach are crucial for helping these individuals navigate the challenges of sustaining healthy living and making ongoing adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ups and downs of lifestyle modification: An existential journey among persons with severe obesity. Toft, BS., Hörberg, U., Rasmussen, B.[2022]

An online lifestyle intervention coaching protocol was developed based on the Diabetes Prevention Program, aiming to provide effective obesity treatment in primary care settings.

This e-counseling approach allows for high-quality lifestyle advice to be accessible to patients who cannot attend in-person sessions due to scheduling or geographic limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an online diabetes prevention lifestyle intervention coaching protocol for use in primary care practice. Simkin-Silverman, LR., Conroy, MB., Bhargava, T., et al.[2018]

In the Look AHEAD trial, severely obese participants (BMI ≥40 kg/m²) who underwent an intensive lifestyle intervention (ILI) lost an average of 9.04% of their initial body weight after one year, which was significantly more than the 7.43% weight loss in overweight participants, showing that ILI is effective for severe obesity.

All groups, including severely obese participants, showed similar improvements in cardiovascular disease risk factors such as fitness, LDL cholesterol, and blood pressure, indicating that intensive lifestyle changes can benefit individuals regardless of their initial weight category.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of lifestyle interventions for individuals with severe obesity and type 2 diabetes: results from the Look AHEAD trial. Unick, JL., Beavers, D., Jakicic, JM., et al.[2022]

A randomized clinical trial involving 445 participants showed that individual telephone counseling for obesity management significantly reduced weight regain compared to an email education control, with a posterior probability greater than 99%.

Participants receiving individual telephone counseling were more likely to achieve at least a 10% weight reduction (31.5%) compared to those in the control group (19.1%), indicating that personalized support can enhance long-term weight loss maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Telehealth Extended Care for Maintenance of Weight Loss in Rural US Communities: A Randomized Clinical Trial. Perri, MG., Shankar, MN., Daniels, MJ., et al.[2020]

A new mathematical model was developed to predict weight changes based on dietary energy intake, using data from 8 longitudinal studies with 157 participants, which showed strong accuracy in its predictions (R² values of 0.83 and 0.91).

This model can help obese patients and their doctors set realistic long-term weight maintenance goals by calculating the necessary dietary changes, making it a practical tool for weight management professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling weight-loss maintenance to help prevent body weight regain. Hall, KD., Jordan, PN.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2405457724014876

Nutrigenomics-guided lifestyle intervention programmes Nutrigenomics-guided programs use genetic testing for personalized health recommendations, but the review shows mixed results and few studies, mainly in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2682937/

Nutrigenomic Analysis of Diet-Gene Interactions on Functional ... Nutrigenomics may provide the strategies for the development of safe and effective dietary interventions against the obesity epidemic. According to the World ...

3. nutrigenomix.com nutrigenomix.com/science

Genetic Testing for Personalized Nutrition In a randomized controlled study, a high-protein diet resulted in a 2-fold greater loss in total body fat, visceral fat and subcutaneous fat compared to a low ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7664486/

Enhanced long-term dietary change and adherence in a ... The study found that nutrigenomics-guided interventions significantly reduced fat intake and improved long-term dietary adherence compared to ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03015012

Study Details | NCT03015012 | Nutrigenomics, Overweight/ ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

6. mygenefood.com mygenefood.com/blog/nutrigenomix-review/

Nutrigenomix Review: Weighing the Pros and Cons The Nutrigenomix test is the only nutrigenetics test validated by a randomized controlled clinical trial looking into DNA-based dietary advice.

7. mdpi.com mdpi.com/2075-1729/15/11/1658

Nutrigenomics of Obesity: Integrating Genomics ... This review systematically consolidates emerging insights into the molecular and nutrigenomic architecture of obesity by integrating data from large-scale GWAS, ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0899900725002357

From gene to plate: Nutritional genomics and the second ... The results of nutrigenomics are derived from research on nutritional intervention strategies that, in the end, prevent diet-related diseases. Dietary ...